Did you know that many medicines children take have yet to be formally tested on children?
This means that doctors often prescribe drugs based on how they work in adults rather than in children. But children are not just smaller versions of adults. They have different needs and responses to medicines than adults do. That's why it's essential to conduct pediatric clinical research studies.
What Are Pediatric Clinical Research Studies?
Pediatric clinical research studies are scientific investigations that test how drugs work in children. They can help:
Find the correct dose of medicines for children;
Discover therapies for diseases that behave differently in adults and children; and
Improve children's overall health and well-being.
Getting Started in a Pediatric Clinical Study:
If you want to join your child in a pediatric clinical study, you might wonder what to expect and who will be involved.
A clinical study is a research project that tests new ways to prevent, diagnose, or treat diseases or conditions in children.
A clinical study team is a group of experts who plan, conduct, and oversee the study. The team includes doctors, nurses, study coordinators, pharmacists, and others with special training and experience working with children.
The team's role is to ensure that your child meets the criteria for the study, performs the necessary tests and procedures, provides the study medication (if any), monitors your child's health and safety, and follows the rules and regulations of the study.
But the most critical member of the team is you and your child. You and your child have the right to be informed and involved in every aspect of the study.
You can ask questions, share your concerns, and give feedback anytime. You can also withdraw your child from the study at any time without affecting your child's regular care. By participating in a pediatric clinical study, you and your child can contribute to scientific knowledge and help improve other children's health.
Not All Children are eligible
The first step of the clinical study process is enrollment. To join a clinical study, participants must meet specific requirements. These requirements are called inclusion and exclusion criteria, and they depend on factors such as age, general health status, and type of illness. If your child qualifies for a clinical study, you will need to give permission, and your child will need to give consent. Then, your child may be assigned to a specific research-treatment group.
Giving Informed Consent
Informed consent is a critical step in the enrollment process. As a parent, you will get an informed consent form, or a parental permission document, if your child qualifies for the study. This form has detailed information about the clinical research, the tests, the possible benefits and risks of the study drug, and how your child's medical information will be protected.
The form is meant to help you and your child understand the clinical trial and your rights as participants.
You should read the document carefully and ask any questions you have. A member of the clinical study team will explain the study to you and your child in a way they can understand.
Your child can also ask questions and share any worries they have. You will sign the document if you agree to let your child join the study.
You and your child can choose not to join the study at anytime. You will be told about other treatment options if you don't want your child to be in the study.
Children's participation in clinical studies requires the informed consent of their parents or caregivers and the children's permission, according to their age and comprehension level.
The term "assent" refers to the voluntary agreement of the child or adolescent to join the research. The child's permission is necessary in addition to the consent of the parent or caregiver, depending on the study's age and nature.
This ensures that the children are not coerced or pressured to be in the study by their parents, caregivers, or the clinical study team.
The child must understand and accept a pediatric clinical study's medication, tests, risks, and benefits. Children in clinical studies should always communicate their concerns with their parents, caregivers, or the clinical study team.
Protecting Your Child's Rights
As a parent, you want to ensure your child is cared for during a clinical study.
The study team follows strict ethical and legal standards to ensure your child's welfare. An independent group of experts, an institutional review board (IRB), reviews and approves the study before it starts.
Ensure that the survey follows international guidelines and respects the rights of the participants. You and your child have the right to withdraw from the study at any time without giving any reason.
Children who participate in clinical studies are protected by rules and regulations set by governmental and health authorities worldwide.
These rules ensure that the risks to children and adolescents are as low as possible and are balanced by the potential benefits. If you have any questions or concerns about the safety measures in your child's clinical study, you can always talk to a study team member.